Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
NCT ID: NCT00606905
Last Updated: 2012-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
1999-11-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution
Gamimune N or Gamunex 10%
500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
2
normal saline
normal saline
equivalent volume of normal saline
Interventions
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Gamimune N or Gamunex 10%
500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
normal saline
equivalent volume of normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Most recent pregnancy occurred within one year of discontinuing contraception.
Exclusion Criteria
* Maternal history of immunoglobulin hypersensitivity.
* Maternal contraindication to pregnancy.
* Evidence of active hepatitis or immunocompromised state in either partner.
* Concomitant use of medication(s) for treatment of recurrent miscarriage, such as but not limited to progesterone, clomiphene citrate, acetylsalicylic acid, heparin, glucocorticoids or hCG injections.
18 Years
45 Years
FEMALE
No
Sponsors
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University of British Columbia
OTHER
University of Tennessee
OTHER
Sunnybrook Health Sciences Centre
OTHER
Grifols Therapeutics LLC
INDUSTRY
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Mary D Stephenson, MD, MSc
Role: STUDY_CHAIR
University of Chicago
William Kutteh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Tennesee
Susan Purkiss, MD
Role: PRINCIPAL_INVESTIGATOR
The University of British Columbia
Cliff Librach, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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The University of Chicago
Chicago, Illinois, United States
Countries
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References
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Stephenson MD, Kutteh WH, Purkiss S, Librach C, Schultz P, Houlihan E, Liao C. Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a multicentered randomized placebo-controlled trial. Hum Reprod. 2010 Sep;25(9):2203-9. doi: 10.1093/humrep/deq179. Epub 2010 Jul 15.
Other Identifiers
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PHS M01 RR00055
Identifier Type: -
Identifier Source: secondary_id
13157A
Identifier Type: -
Identifier Source: org_study_id